Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-27 @ 1:02 PM
Study NCT ID:
NCT06670950
Status:
RECRUITING
Last Update Posted:
2024-11-01
First Post:
2024-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Single Dose and Multiple Ascending Dose Study to Assess the Relative Bioavailability, Food Effect, Safety, Tolerability and Pharmacokinetics of SYT-510 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2024-10-29', 'studyFirstSubmitQcDate': '2024-10-31', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Maximum Observed Concentration (Cmax) of SYT-510', 'timeFrame': 'Up to 72 hours post-dose'}, {'measure': 'Part 1: Area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-tlast) of SYT-510', 'timeFrame': 'Up to 72 hours post-dose'}, {'measure': 'Part 1: AUC of SYT-510', 'timeFrame': 'Up to several days post last dose'}, {'measure': 'Part 2: Incidence and severity of treatment related adverse event, including abnormal laboratory events to evaluate the safety and tolerability profile of multiple ascending doses of SYT-510', 'timeFrame': 'Up to Day 20'}], 'secondaryOutcomes': [{'measure': 'Part 1: Incidence and severity of treatment related adverse event, including abnormal laboratory events to evaluate the safety and tolerability profile of single doses of SYT-510', 'timeFrame': 'Up to Day 4'}, {'measure': 'Part 2: Maximum observed concentration (Cmax) of SYT-510', 'timeFrame': 'Up to Day 14'}, {'measure': 'Part 2: Time of maximal plasma concentration (tmax) of SYT-510', 'timeFrame': 'Up to Day 14'}, {'measure': 'Part 2: AUCtau of SYT-510', 'timeFrame': 'Up to Day 14'}, {'measure': 'Part 2: Terminal elimination half-life (t1/2) of SYT-510', 'timeFrame': 'Up to several days post last dose'}, {'measure': 'Part 2: Accumulation ratio of SYT-510', 'timeFrame': 'Up to Day 14'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Part 1 aims to investigate the relative bioavailability of a new formulation and to assess potential food effects following oral administration of SYT-510. Part 1 will then guide dosing in Part 2, a multiple dose study which aims to assess safety, tolerability and pharmacokinetic of multiple SYT-510 administrations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Male and female participants of non-childbearing potential', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females of non-childbearing potential (WOCBP) aged 18 to 65 years old (inclusive) at the date of signing the informed consent form (ICF).\n* Normal ECG, showing no clinically relevant deviations, as judged by the investigator.\n* Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at Screening and Admission (e.g Day -1 or Day -2) and a minimum weight of 50kg.\n\nExclusion Criteria:\n\n* Current or recurrent disease that as judged by the Investigator may interfere with the execution of the conduct of the study.\n* Laboratory parameters outside of the laboratory normal range.\n* Positive test results for alcohol or drugs of abuse.\n* Treatment with an investigational drug within 90 days preceding the first dose of trial medication.\n* Known or suspected intolerance or hypersensitivity to the investigational product, any closely related compound, or any of the stated ingredients.\n* History of significant allergic reactions (anaphylaxis, angioedema) to any product (food, pharmaceutical, etc).\n* Current smokers and those who have smoked within the last 6 months.'}, 'identificationModule': {'nctId': 'NCT06670950', 'briefTitle': 'A Phase 1 Single Dose and Multiple Ascending Dose Study to Assess the Relative Bioavailability, Food Effect, Safety, Tolerability and Pharmacokinetics of SYT-510 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Synendos Therapeutics AG'}, 'officialTitle': 'A Two-Part Study Investigating the Relative Bioavailability and the Potential Food Effect After a Single Oral Dose Administration of a New Formulation of SYT-510, and the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Oral Dose Administration of SYT-510 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'SYN510CT02'}, 'secondaryIdInfos': [{'id': '1010456', 'type': 'REGISTRY', 'domain': 'IRAS ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Relative bioavailability and food effect', 'description': 'Randomised, open label, single-dose, three period, three-sequence crossover study to evaluate the relative bioavailability (rBA) of a new oral formulation of SYT-510 under fasting conditions and the effect of food in healthy participants.', 'interventionNames': ['Drug: SYT-510']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Multiple Ascending Dose', 'description': 'Randomised, double-blind, placebo-controlled multiple ascending dose (MAD) study in healthy participants to assess the safety, tolerability and pharmacokinetics (PK) of SYT-510 after repeated administrations.', 'interventionNames': ['Drug: SYT-510', 'Drug: Placebo']}], 'interventions': [{'name': 'SYT-510', 'type': 'DRUG', 'description': 'Oral formulation A fasted', 'armGroupLabels': ['Part 1: Relative bioavailability and food effect', 'Part 2: Multiple Ascending Dose']}, {'name': 'SYT-510', 'type': 'DRUG', 'description': 'Oral formulation B fasted', 'armGroupLabels': ['Part 1: Relative bioavailability and food effect']}, {'name': 'SYT-510', 'type': 'DRUG', 'description': 'Oral formulation A fed', 'armGroupLabels': ['Part 1: Relative bioavailability and food effect']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral formulation', 'armGroupLabels': ['Part 2: Multiple Ascending Dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Principal Investigator', 'role': 'CONTACT', 'email': 'do@richmondpharmacology.com', 'phone': '+44 2070425800'}], 'facility': 'Richmond Pharmacology Ltd', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Synendos Therapeutics AG', 'role': 'CONTACT', 'email': 'info@synendos.com', 'phone': '+41783008789'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Synendos Therapeutics AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}